inv-01: Articular Cartilage Repair (non-knee) — Not medically necessary for articular cartilage defects in joints other than the knee
Articular Cartilage Repair
Each of the following procedures is considered not medically necessary for treatment of articular cartilage defects involving joints other than the distal femur and patellar articular cartilage within the knee (e.g., ankle, elbow, shoulder):
autologous chondrocyte implantation (e.g., Carticel®, MACI® [Vericel Corporation, Cambridge, MA])
osteochondral allograft transplantation
osteochondral autograft transplantation
inv-02: Experimental / Investigational Procedures — list of procedures considered experimental, investigational, or unproven
Articular cartilage repair using ANY of the following, for any joint, is considered experimental, investigational or unproven:
cartilage regeneration membrane (e.g., Chondro-Gide®)
xenograft implantation into the articular surface
synthetic resorbable polymers (e.g., PolyGraft™ BGS, TruFit® [cylindrical plug], TruGraft™ [granules])
juvenile cartilage allograft tissue implantation, including minced cartilage (e.g., DeNovo® NT Natural Tissue Graft, DeNovo® ET™ Engineered Tissue Graft; BioCartilage®)
decellularized osteochondral allograft implant (e.g., Chondrofix® Osteochondral Allograft)
inv-03: Ligament Allograft — Medically necessary when indicated
Ligament/Meniscus Reconstruction
Ligament allograft materials are considered medically necessary when medical necessity has been established for the associated primary procedure.
Example: anterior cruciate ligament allograft
inv-04: Intra-articular Corticosteroid Injection Limits — Coverage limits and frequency constraints
Intra-articular corticosteroid injections for the treatment of chronic, osteoarthritic joint pain are not covered or reimbursable when administered more frequently than either of the following:
four injections during a rolling 12 month year
two injections on the same day
inv-05: Healing Response Technique — Not medically necessary
Healing response microfracture technique for treatment of intra-articular ligament injury is considered not medically necessary due to insufficient evidence of safety and efficacy.
Healing response microfracture technique (e.g., biologic healing response)
inv-10: Subchondroplasty — investigational / insufficient evidence
Subchondroplasty for the treatment of a subchondral bone defect is considered experimental, investigational or unproven.
Subchondroplasty (injection of bone void filler into subchondral bone defect)
inv-11: Percutaneous ultrasonic ablation — limited evidence
Percutaneous ablation of soft tissue for treatment of any musculoskeletal condition (e.g., tendinosis, tendinopathy) is considered experimental, investigational or unproven.
Percutaneous ultrasonic ablation / tenotomy (e.g., Tenex Health TX System®)
inv-12: In-office arthroscopy — limited evidence
In-office diagnostic arthroscopy of any upper or lower extremity joint for evaluation of joint pain and/or pathology is considered experimental, investigational or unproven.
In-office needle arthroscopy systems (e.g., Mi-Eye2™, VisionScope®)
inv-13: MISHA — limited peer-reviewed evidence despite FDA De Novo
Medial knee implanted shock absorber (e.g., MISHA™ Knee System) is considered experimental, investigational or unproven for any indication, including management of osteoarthritis.
MISHA™ Knee System (medial knee extraarticular implantable shock absorber)
inv-14: Thermal shrinkage — not supported by robust evidence / high failure rates
Thermal shrinkage (arthroscopic thermal capsulorrhaphy, electrothermal arthroscopic capsulorrhaphy, radiofrequency thermal shrinkage) is considered experimental, investigational or unproven for treatment of joint capsule, ligament, or tendon conditions.
Thermal capsulorrhaphy / thermal shrinkage for shoulder, knee (ACL/PCL), ankle, hip, hand/wrist
inv-15: Thermal shrinkage — evidence-based conclusion and coverage stance
Thermal shrinkage procedures have demonstrated high failure rates in some series and insufficient long-term durability; therefore thermal shrinkage is considered not medically necessary or experimental depending on the indication.
Thermal shrinkage with arthroscopy codes and unlisted procedure coding
inv-16: Coverage determinations for related procedures/materials — coverage designations
Coverage determinations for related procedures and materials: codes and status summaries are provided below.
Osteochondral allograft of talus may be considered when criteria met; literature shows mixed outcomes compared to autograft and insufficient evidence for joints other than knee.
Decellularized cartilage (e.g., Chondrofix®) and synthetic polymers have limited/poor outcomes in some reports and are considered unproven.
A variety of procedures (meniscal scaffolds, subchondroplasty, ultrasonic ablation, in-office arthroscopy, MISHA, thermal shrinkage) have limited evidence and are considered experimental or investigational.
Note: J7330 and L8699 are considered Experimental/Investigational/Unproven when used to report xenograft implant and cartilage regeneration membrane products for articular cartilage repair.
Considered Experimental/Investigational/Unproven when used to report articular cartilage repair of any joint: 0737T = Xenograft implantation into the articular surface.
These materials (e.g., PolyGraft BGS, TruFit, TruGraft, DeNovo NT/ET, BioCartilage, Chondrofix) lack sufficient high-quality evidence to support routine use for articular cartilage repair outside of investigational settings.
Note: Ligament allograft materials are considered medically necessary when medical necessity has been established for the associated primary procedure. Menaflex™ had 510(k) clearance rescinded by the FDA; Actifit® has received Breakthrough Designation but lacks full FDA approval.
Healing response technique (code 29999) is explicitly listed as not medically necessary for this policy.
Subchondroplasty codes are listed as experimental/investigational/unproven for any joint due to insufficient evidence and lack of long-term outcome data.
In-office diagnostic arthroscopy systems are considered experimental/investigational due to limited peer-reviewed evidence demonstrating impact on health outcomes.
Percutaneous ultrasonic ablation codes are listed as experimental/investigational/unproven because current literature is limited to small case series and lacks high-quality comparative trials.
Although the MISHA system received FDA De Novo authorization, peer-reviewed clinical evidence is limited and does not yet demonstrate improved net health outcomes; therefore use is considered experimental/investigational/unproven.
Thermal capsulorrhaphy and related thermal procedures are considered experimental/investigational/unproven given inconsistent evidence, high failure rates in some series, and safety concerns.